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NCT00628251 · OUTCOME

Overall Duration of Response

Dose-finding Study Comparing Efficacy and Safety of a PARP Inhibitor Against Doxil in BRCA+ve Advanced Ovarian Cancer · Source last updated 2019-12-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)

What was measured

The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)

Analysis population: Duration of response is analysed for patients experiencing a response.

Groups in this outcome

Olaparib 200 mg bd

Olaparib (AZD2281) 200 mg oral capsules twice daily

Olaparib 400 mg bd

Olaparib (AZD2281) 400 mg oral capsules twice daily

Olaparib 200 mg bd + Olaparib 400 mg bd,

Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily

Liposomal Doxorubicin

Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Olaparib 200 mg bd8
Olaparib 400 mg bd10
Olaparib 200 mg bd + Olaparib 400 mg bd,18
Liposomal Doxorubicin6

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Olaparib 200 mg bd5.95Not reported3.71NAThe upper limit for the 95% CI was not reached.
Olaparib 400 mg bd6.80Not reported5.527.39Not reported
Olaparib 200 mg bd + Olaparib 400 mg bd,6.24Not reported5.527.39Not reported
Liposomal Doxorubicin5.49Not reported4.679.13Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        The upper limit for the 95% CI was not reached.
        group Id
        OG000
        lower Limit
        3.71
        upper Limit
        NA
        value
        5.95
      2. group Id
        OG001
        lower Limit
        5.52
        upper Limit
        7.39
        value
        6.80
      3. group Id
        OG002
        lower Limit
        5.52
        upper Limit
        7.39
        value
        6.24
      4. group Id
        OG003
        lower Limit
        4.67
        upper Limit
        9.13
        value
        5.49
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      6
    units
    Participants
description
The duration of response was defined as time (months) from initial assessment of PR/CR until earliest date of objective progression or death. (Values may be underestimated as some patients had not progressed at final analysis so true duration is likely to be greater than that in database.)
dispersion Type
95% Confidence Interval
groups
  1. description
    Olaparib (AZD2281) 200 mg oral capsules twice daily
    id
    OG000
    title
    Olaparib 200 mg bd
  2. description
    Olaparib (AZD2281) 400 mg oral capsules twice daily
    id
    OG001
    title
    Olaparib 400 mg bd
  3. description
    Olaparib (AZD2281) 200 or 400 mg oral capsules twice daily
    id
    OG002
    title
    Olaparib 200 mg bd + Olaparib 400 mg bd,
  4. description
    Liposomal doxorubicin 50 mg/m2 intravenously every 4 weeks
    id
    OG003
    title
    Liposomal Doxorubicin
param Type
MEDIAN
population Description
Duration of response is analysed for patients experiencing a response.
reporting Status
POSTED
time Frame
At the time that 57 PFS events had occurred (Data cut-off for primary analysis of PFS: 15 September 2009)
title
Overall Duration of Response
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice